Jobs at Syner-G

Leads CMC drug substance and drug product development programs across client engagements. Manages integrated project plans, clinical supplies forecasting and distribution, packaging and labeling, budgets, risks, vendors, timelines, and cross-functional stakeholders. Facilitates governance and client meetings, prepares status reporting, supports regulatory activities, maintains client relationships, and contributes to business development. The role may require travel to client sites up to 100% based on project needs.

Lead development and implementation of a terminal sterilization program: define sterilization cycles and recipes, support commissioning/validation, ensure GMP and regulatory compliance, troubleshoot cycle development, train operations, and partner with CQV, engineering, and manufacturing to enable manufacturing readiness.

Lead end-to-end recruitment for India: partner with leaders to design hiring strategies, source and screen candidates using ATS and sourcing platforms, manage interviews and offers, build pipelines, improve processes, support onboarding and employer branding, and advise on market and compensation trends.

Lead business analysis, requirements definition, system administration, integration development, and reporting for enterprise systems and data initiatives. Partner with stakeholders to design solutions, manage user access, troubleshoot systems, support upgrades and migrations, and develop reporting in Kantata, NetSuite, Salesforce, and Power BI.

Serve as a strategic partner to executive leadership, translating priorities into actionable programs, governance, and measurable outcomes. Lead cross-functional product development and business initiatives, drive executive operating rhythms, build dashboards and KPIs, manage portfolio health and risks, and ensure accountability across research, quality, regulatory, manufacturing, supply chain, and commercial functions.

Lead strategic program management for cross-functional product development initiatives in life sciences, from concept through commercialization. Establish governance, manage risks and milestones, drive executive alignment, prepare executive reporting, and coordinate research, engineering, quality, regulatory, manufacturing, and commercial teams to ensure product launch and commercialization readiness.

Lead reliability engineering for critical facility systems in life-sciences environments: manage CMMS, develop preventive/predictive maintenance strategies, perform FMEA/RCM/RCFA, analyze equipment performance, plan maintenance, support commissioning/qualification, drive continuous improvement, and ensure compliance with GMP and safety requirements.

Administer and maintain the site's CMMS: manage equipment records, work orders, storeroom/inventory, training records, service contracts, and reporting. Support Maintenance, Calibration, and Facilities operations, write/revise SOPs, participate in continuous improvement, and ensure GxP-compliant recordkeeping and safety adherence.

Lead regional technical operations and account strategy for life-sciences client projects in the Southeast. Manage P&L, build and mentor engineering teams, drive client retention and business development, oversee project delivery for GMP laboratory and manufacturing facility design, construction, startup and operations, and collaborate with cross-functional teams to pursue growth and minimize risk.

Lead integrated Verification and Commissioning & Qualification (C&Q) programs for large GMP capital projects using ASTM E2500 principles. Manage scope, budget, schedule, resources, risks, and cross-functional teams through design, construction, startup, verification, system turnover, and operational handover. Oversee development and execution of verification plans, testing, documentation, and regulatory compliance while mentoring teams and supporting audits and client interactions.

Serve as owners representative on large, complex lab/office or cGMP construction projects from design through commissioning. Write commissioning plans, review technical submissions, supervise subcontractor commissioning teams, coordinate equipment moves, ensure safety and cGMP compliance, use construction management software and CMMS, write SOPs, and close out projects with complete documentation and financial reconciliation.

Coordinate construction and maintenance project safety activities: organize pre-construction meetings, maintain schedules and safety documentation, review contractor safety submissions, support site walks and incident investigations, compile safety metrics, assist with contract administration, and enable cross-team communication to ensure compliance and hazard resolution.

Lead process optimization and commercial manufacturing support for oral solid dose (OSD) operations. Support tech transfer, troubleshoot process and yield issues, lead PPQ and continued process verification, collaborate with MSAT/Manufacturing/QA/Engineering, develop process documentation, analyze performance trends, support equipment qualification/start-up, and mentor junior engineers to drive throughput, yield, cost reduction, and GMP compliance.

Manage construction and engineering capital projects from planning through commissioning and closeout. Coordinate contractors and A&E deliverables, maintain schedules and budgets, perform site walks, oversee commissioning and turnover of building systems, enforce safety and documentation standards, and act as owner's representative to ensure project delivery and regulatory/audit readiness.

Lead regulatory strategy for clients across drug development stages, author and submit NDA/BLA/IND materials, manage FDA interactions (Type A/B/C), coordinate global submissions, evaluate manufacturing/quality impacts, mentor staff, and provide regulatory advice and industry thought leadership.

Lead analytical development for oligonucleotide and peptide products across clinical phases: design, validate, and execute methods; perform characterization and stability testing; manage CDMO method transfers and comparability protocols; prepare regulatory submissions (IND/CTA); collaborate with CMC teams; mentor junior staff; and support project timelines and stakeholder communications.

General company overview and invitation to submit a general application for future roles across Syner-G. Applicants are encouraged to apply for consideration; the recruiting team will contact candidates when a suitable position opens.

Lead Syner-G's West Coast biologics practice, drive business development, and personally deliver biologics CMC consulting across upstream/downstream/analytical/formulation. Author CMC regulatory submissions (INDs, BLAs), mentor staff, build regional team, and represent the firm at industry events. Role requires deep technical ownership and frequent client travel.

Lead ~10 concurrent monoclonal antibody drug substance technology transfers from process handoff through GMP manufacturing, PPQ and commercialization. Provide MSAT technical leadership across upstream/downstream operations, develop governance and risk-based validation strategies, support commissioning/startup, drive portfolio reporting and resource planning, troubleshoot processes, and mentor engineering staff.

Lead enterprise AI strategy, prioritize high-value use cases, and oversee end-to-end model development, MLOps, governance, deployment, and adoption. Build and mentor AI teams, partner with technology and business units, manage vendors and budgets, and measure business impact while ensuring responsible AI practices and stakeholder alignment.